Study to evaluate whether botanical extract reduces Long Covid–associated fatigue.
Front Range Pharmaceuticals, a company based near Denver, Colorado, is developing plant-based treatments for people with diseases inadequately addressed by conventional medicines. Next year, the company will start enrolling adults with severe fatigue associated with Long Covid for a year-long phase 2 of FRP-003, a hemp-flower extract. The trial will evaluate whether FRP-003 reduces fatigue and improves other symptoms.
FRP-003 is an oil-based preparation made from the entire flower of the hemp plant and has high levels of cannabinoids and terpenes. Plants use these chemicals to adapt to and defend against environmental stresses. For thousands of years, people have used cannabinoid- and terpene-rich plant extracts as medicines because cannabinoids regulate diverse functions in people, including appetite, immune functions, mood, pain, sleep, and stress responses. In an earlier, exploratory study, people with Long Covid who took FRP-003 every day had less anxiety and better sleep.
The company plans to begin enrolling participants in 2027 and expects the study to take a year to complete. The trial will enroll about 220 adults (aged 18–65 years) at multiple study centers. Eligible participants will have Long Covid characterized mainly by severe fatigue, but also by post-exertional malaise and limited daily functioning. The study will be randomized, double-blinded, and placebo-controlled. Participants will take a lower dose of FRP-003, a higher dose, or placebo by mouth every day for 56 days. The primary focus will be whether FRP-003 reduces fatigue. The study will also assess safety and whether treatment reduces anxiety and inflammation and improves cognition, daily functioning, immune functions, quality of life, and sleep.
The company notes that similar plant extracts have helped people with diseases that resemble Long Covid. Because no approved treatment is approved for people with Long Covid and because conventional methods often do not help manage symptoms, alternative approaches should be considered, they say.
Said Isaac Foster, Front Range’s CEO, “Persistent fatigue and post-exertional symptoms can profoundly affect daily functioning in people with Long COVID, yet there are currently no FDA-approved treatments for the condition. Our Phase 2 study is designed to determine whether FRP-003 can meaningfully improve fatigue while also helping us identify the appropriate dose for future development.”
It should be noted that the earlier studies raised important concerns that must be addressed. In one earlier study, people taking placebo improved in several measures as much as or more than people taking FRP-003. Also, these earlier studies were too small to draw meaningful conclusions. This phase 2 trial will therefore need to show clearer evidence of benefit and safety before FRP-003 could advance to phase 3 testing. Other companies and investigators have also studied similar treatments for helping people with Long Covid (e.g., NCT04997395, NCT04777981, NCT05467904).
The study has yet to be listed on ClinicalTrials.gov. But those interested in participating may look for updates on the company’s website. People should also speak with their health care providers when considering participating.
